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Related Concept Videos

Clinical Trials01:16

Clinical Trials

11.0K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
11.0K
Combination Therapies and Personalized Medicine02:50

Combination Therapies and Personalized Medicine

6.3K
Combining two or more treatment methods increases the life span of cancer patients while reducing damage to vital organs or tissue from the overuse of a single treatment. Combination therapy also targets different cancer-inducing pathways, thus reducing the chances of developing resistance to treatment.
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...
6.3K
Pharmacogenomics: Identification of New Drug Targets01:29

Pharmacogenomics: Identification of New Drug Targets

56
Advances in genomics have profoundly influenced drug discovery by increasing both the speed and accuracy of pharmaceutical development. Pharmacogenomics, which examines how genetic variation influences drug response, facilitates the identification of novel therapeutic targets and enables patient stratification for personalized treatment. These strategies contribute to improved drug efficacy, minimized adverse effects, and more efficient clinical trial design.Mapping genetic differences...
56
Clinical Trials: Overview01:11

Clinical Trials: Overview

5.2K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
5.2K
Blinding01:11

Blinding

4.0K
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
4.0K
Hazard Ratio01:12

Hazard Ratio

670
The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
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Updated: Mar 7, 2026

Integration of Wet and Dry Bench Processes Optimizes Targeted Next-generation Sequencing of Low-quality and Low-quantity Tumor Biopsies
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Integration of Wet and Dry Bench Processes Optimizes Targeted Next-generation Sequencing of Low-quality and Low-quantity Tumor Biopsies

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Precision medicine needs randomized clinical trials.

Everardo D Saad1, Xavier Paoletti2, Tomasz Burzykowski3

  • 1International Drug Development Institute (IDDI), Avenue Provinciale 30, 1340 Ottignies-Louvain-la-Neuve, Belgium.

Nature Reviews. Clinical Oncology
|February 8, 2017
PubMed
Summary
This summary is machine-generated.

Randomized trials are crucial for validating new cancer drugs, even with promising early results. Uncontrolled trials may overestimate treatment effects, hindering accurate drug and biomarker development.

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Area of Science:

  • Oncology
  • Clinical Trials
  • Precision Medicine

Background:

  • Precision medicine is transforming cancer research, leading to numerous new therapies.
  • The approval of effective drugs based on uncontrolled phase I trials is increasing.
  • This trend challenges traditional clinical trial designs and drug approval processes.

Purpose of the Study:

  • To question the reliance on uncontrolled trials for drug efficacy.
  • To highlight the necessity of randomized controlled trials (RCTs) in drug development.
  • To emphasize the role of randomization in validating biomarkers and facilitating seamless development phases.

Main Methods:

  • Discussion of evidence from uncontrolled phase I trials.
  • Analysis of the limitations of single-arm trials in assessing treatment effects.
  • Examination of the role of biomarkers and companion testing in drug development.

Main Results:

  • Uncontrolled trials may overestimate treatment efficacy due to prognostic factors.
  • Randomization is essential to definitively ascertain the predictive role of biomarkers.
  • Expedited drug approval based on uncontrolled trials carries significant disadvantages.

Conclusions:

  • Randomized trials with a true control arm are necessary throughout drug development.
  • Increased use of randomization supports smoother transitions in drug and biomarker development.
  • RCTs are vital for accurate assessment of novel cancer therapeutics and companion diagnostics.